Graft introducer

ABSTRACT

An instrument for placing a graft into a bone tunnel comprises an elongated shaft having a forked distal end comprising a pair of tines. A suture spans a space defined between the tines whereby the graft may be positioned between the tines and against the suture so as to be manipulated into the bone tunnel. The tendon folds about the suture, the suture having a releasable tension such that the instrument can be removed from the bone, leaving the tendon behind without the tendon hanging up on the suture.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. patent applicationSer. No. 13/247,180, entitled GRAFT INTRODUCER, filed Sep. 28, 2011,which is incorporated herein by reference.

BACKGROUND

This application relates to tissue manipulation instruments, and moreparticularly to instruments for implantation of graft tissue into a bonehole.

In certain surgical procedures, such as tenodesis, a graft tissue isattached to a bone. For instance, in tenodesis a biceps tendon isdetached from its attachment to the glenoid and is reattached to thehumerus. In one popular method of reattachment a bone tunnel is createdon the humerus and the detached tendon is pushed into the tunnel andthen held in place via an interference bone screw implanted into thetunnel. Positioning the tendon in the tunnel can be tricky.

In one method, the graft tissue is externalized from the patient andwhip stitched to make a stiff construct at the termination of thetissue. The stiff construct may be pushed directly into tunnel usinggraspers or the like. A length of suture at the distal portion of thewhip stitch may be used to pull the graft tissue into the tunnel. It isdesirable in many cases, however, to perform the entire operation withthe graft tissue internalized within the patient. Thus, producing thewhip stitch is difficult for the surgeon.

In another method, the graft tissue is folded near the location oftunnel and pushed into the tunnel at the fold. When usinginstrumentation of prior art, the graft tissue has a natural tendency tocompress against the instrument. Should the frictional contact betweenthe graft tissue and instrument be greater than the frictional contactbetween the graft tissue and tunnel, it is likely that the tissue willmove from its desired position as the instrument is retracted from thetunnel.

SUMMARY OF THE INVENTION

The present invention overcomes these and other limitations of the priorart in a simple and elegant design.

An instrument according to the present invention provides for implantinga graft into a bone hole. The instrument comprises an elongated handlehaving a forked distal termination having a first tine and a second tinedefining a space therebetween. A flexible member spans the space betweenthe first tine and the second tine so that the graft can be receivedwithin the space against the flexible member and thereby manipulatedinto the bone hole.

Preferably, the first tine comprises an open ended first notch at itsdistal end, the flexible member being received within the first notch.Preferably, the flexible member having a first section between the firsttine and second tine, and a second section extending from the firstnotch proximally along the handle where it preferably, is releasablyattached to the handle so that a user can release the flexible memberfrom the handle to relax tension in the flexible member. Preferably, thesecond tine comprises an open ended second notch with the flexiblemember being received in both the first notch and second notch andspanning the space therebetween.

In one aspect of the invention, one or both of the first tine and secondtine are flexible, with the space between the first tine and second tinebeing adjustable by tension on the flexible member.

In one aspect of the invention, the handle is cannulated having alongitudinal cannulation opening to the space between the first tine andsecond tine. In one aspect of the invention, a guide wire is providedwhich is passable through the cannulation and which is adapted to befixed into the bone hole whereby the instrument can be passed down tothe bone hole over the guide wire.

Preferably, the first tine and second tine are curved about a centrallongitudinal axis of the instrument to accommodate to the bone hole.

Preferably, the instrument is provided sterile and packaged in abacteria proof package.

A method according to the present invention provides for implanting agraft into a bone hole. The method comprises the steps of: positioningthe graft between a first tine and a second tine at a distal end of ashaft of a surgical instrument and against a flexible member spanning aspace defined between the first tine and second tine; manipulating thefirst and second tines with the graft therebetween into a bone tunnel;pushing the graft via the flexible member into the bone tunnel; andreleasing tension in the flexible member to allow its movement relativeto at least one of the first tine and second tine and removing the firstand second tines from the bone tunnel, leaving the graft positionedtherein.

Preferably, the graft is folded upon itself over the flexible member.

In one aspect of the invention, the flexible member is received in anopen distally facing notch on the first tine. In one aspect of theinvention, the step of releasing tension on the flexible member includesallowing it to fall outwardly of an open distally facing notch on thefirst tine.

In one aspect of the invention, at least one of the first tine andsecond tines are flexible a distance between them is controlled viatension on the flexible member.

In an aspect of the invention, the first tine and second tines aredirected toward the bone tunnel by passing a guide wire leading from thebone tunnel through a cannulation through the shaft. After the graft hasbeen positioned in the bone tunnel an anchor can be passed into thetunnel to fix the graft therein, preferably by passing the anchor overthe guide wire.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side elevation view of a graft implantation tool accordingto the present invention;

FIG. 2 is a side elevation view of a graft anchor for use with the toolof FIG. 1;

FIG. 3 is a side elevation view of the tool of FIG. 1 shown adjacent abone tunnel and a graft ready for implantation into the tunnel;

FIG. 4 is a side elevation view of the tool of FIG. 1 shown initiallycapturing the graft and entering the tunnel;

FIG. 5 is a side elevation view of the tool of FIG. 1 shown fullyinserted into the tunnel;

FIG. 6 is a side elevation view of the tool of FIG. 1 shown retractingfrom the tunnel leaving the graft in the tunnel;

FIG. 7 is a side elevation view of the tool of FIG. 1 oriented to showthe graft entering the tunnel from the rear of this view and an anchorbeing implanted into the tunnel;

FIG. 8 is a side elevation view of the tunnel and graft of FIG. 7oriented to show the graft entering the tunnel from the left side andillustrating a completed implantation of the graft;

FIG. 9 is a side elevation view of an alternative embodiment of a graftimplantation tool according to the present invention showing flexibletines in a relaxed state;

FIG. 10 is a side elevation view of the tool of FIG. 9 showing the tinesin a collapsed state;

FIG. 11A is a side elevation view of a tine of FIG. 1 showing a suturecapture notch;

FIG. 11B is a side elevation view of a tine of an alternative embodimentof a graft implantation tool according to the present invention showinga suture capture hole;

FIG. 11C is a side elevation view of a tine of an alternative embodimentof a graft implantation tool according to the present invention showingan elongated suture capture hole; and

FIG. 11D is a side elevation view of a tine of an alternative embodimentof a graft implantation tool according to the present invention showingan alternative suture capture notch.

FIG. 11E is a side elevation view of a tine of an alternative embodimentof a graft implantation tool according to the present invention;

FIG. 11F is a side elevation view of a tine of an alternative embodimentof a graft implantation tool according to the present invention;

FIG. 11G is a side elevation view of a tine of an alternative embodimentof a graft implantation tool according to the present invention; and

FIG. 11H is a side elevation view of a tine of an alternative embodimentof a graft implantation tool according to the present invention.

DETAILED DESCRIPTION

FIG. 1 depicts a graft implantation tool 10 according to the presentinvention. It comprises an elongated cannulated shaft 12 with a forkeddistal end 14. The distal end 14 comprises a first tine 16 and secondtine 18 defining a space 20 therebetween. Each of the tines 16 and 18has a distal terminal end 22 with a distal terminal notch 24. A lengthof suture 26 or other flexible material with suitable tensile strengthspans the space 20 between the notches 24. It has a first end 28 affixedto the shaft 12 where the second tine 18 meets the shaft 12. From thereit extends down along an exterior surface 30 of the second tine 18enters the second tine notch 24, spans the space 20, enters the firsttine notch 24 and then extends up the shaft 14 where it is secured in asuture retainer 32, which is shown for illustrative purposes as a simplecleat but any suitable retention can be employed as will be appreciatedby those of skill in the art.

A cannulation 34 extends axially through the shaft 12 and opens into thespace 20 between the tines 16 and 18. The cannulation 34 is wide enoughto pass an interference anchor 36 (see FIG. 2). The tines 16 and 18 arecurved on their exterior surfaces 30 and interior surfaces 38 to fitsnugly into a bone tunnel (not shown in FIG. 1) and to pass the anchor36. One or both of the tines 16 and 18 can be flexible with theirspacing being controlled by tension in the suture 26 spanning the space20. In such event their relaxed position is preferably slightly spreadfrom parallel as they extend distally. This allows a more openpresentation to allow easier loading of a graft (not shown in FIG. 1)into the space 20.

Turning also now to FIG. 2, the anchor 36 comprises an elongated body 40having exterior threads 42, a narrow distal tip 44, a proximal toolrecess 46, such as for receipt of a hex driver, and an axial cannulation47 for passage of a guide wire (not shown in FIGS. 1 and 2). Otherconfigurations can be employed as will be appreciated by those of skillin the art. One suitable anchor is the MILAGRO interference screwavailable from DePuy Mitek, Inc. of Raynham, Mass.

The tool 10 can be fabricated from any biocompatible materials orcombinations thereof providing adequate strength for constructing thecannulated shaft 12 and having adequate elastic properties to providethe flexibility of one or both tines 16, 18 to accommodate variations inthe distance across the space 20. Metallic materials that can be used tomanufacture the instrument of the present invention include stainlesssteel, titanium, alloys of nickel and titanium, or other biocompatiblemetallic materials. It can also be formed of polyethylene,polypropylene, PEEK, or other biocompatible non-absorbable polymers.

Turning also to FIGS. 3 to 6, use of the tool 10 will now be described.FIG. 3 shows a biceps tendon 48 which has been removed from itsplacement on the glenoid (not shown) and is placed adjacent to a bonetunnel 50 which has been prepared in a humerus bone 52. A guide wire 54extends from the tunnel 50. Options for creation of the bone tunnel 50and placement of the guide wire 54 will be apparent to those of skill inthe art. The tool 10 has been passed down over the guide wire 54 and ispositioned adjacent to the tunnel 50. The tendon 48 is positioned overthe tunnel 50 with the suture 26 orthogonal to the tendon 48. As thetines 16 and 18 are pressed into the tunnel 50 (FIG. 4) the tendon 48 isreceived between the tines 16 and 18 and caught upon the suture 26causing the tendon 48 to fold upon itself. The tendon 48 is then presseddown into the bottom of the tunnel 50 as illustrated in FIG. 5. At thistime the suture 26 is released from the suture retainer 32 releasingtension in the suture 26 and allowing removal of the tines 16 and 18without the suture hanging up on the tendon 48 and affecting itsimplantation in the tunnel 50 as illustrated in FIG. 6. The anchor 36can then be implanted, preferably over the guide wire 54 employingtechniques as may be known or become known to those of skill in the art.For instance, FIG. 7 shows the anchor 36 being passed down a cannula 51via a cannulated driver 53 and being threaded into the tunnel 50 to trapthe tendon 48 therein. FIG. 8 illustrates the completed repair.

FIGS. 9 and 10 illustrate an alternative embodiment of a graftimplantation tool 56 according to the present invention. It has flexiblefirst and second tines 58 and 60, respectively, and a suture 62 passingfrom the second tine 60 through a distal notch 64 therein across a space66 between the tines 58 and 60, through a distal notch 64 in the firsttine 58. Under slack tension in the suture 62 distal ends 68 of thetines 58 and 60 spread open allowing easy entry of a graft 66 into thespace 66. Tension on the suture 62 causes the tines 58 and 60 tocollapse inwardly toward each other grasping the graft 66. The narrowingof the tine spacing may also ease its entry into a bone tunnel.

Although shown with tines 16 and 18 which are axially aligned with theshaft 12 they could be angled with respect to the shaft 12. Also theshaft could be curved. Various depths of the notches 24 into the tines16 and 18 may be employed for positioning the graft tendon 48 atdifferent axial positions along the tines 16 and 18. The tension on thesuture 26 can also affect such placement with a bit of slack in itbetween the notches 24 allowing the suture 26 to bow proximally as thetendon 48 is engaged. Turning also now to FIGS. 11 A to H, the axialnotch 24 as disclosed in FIG. 1 and FIG. 11A is preferred in the firsttine 16 for easy release of the suture 26 from the tendon 48 after itsimplantation without the suture 26 catching on tendon 48 or the tine 16.Other designs may enhance temporary holding of the suture 26 so that itdoes not fall out of place. For instance a closed circular hole 70,elongated hole 72 or elongated notch 74 with a capture leg 76 or notch80 and more aggressive capture leg 82 may be substituted especially inthe second tine 18. A notch 84 having an expanded capture leg 86 and arestriction 88 leading into the capture leg 86 allows suture to slip ineasily but not slip back out. A notch 89 with a restriction 90 providessome measure of capture but still allows the suture to be extracted fromthe notch 89 if desired. A notch 92 can be provided with a tortuous pathsuch as in inward spiral 94. These designs limit suture 26 from fallingout of the notch inadvertently yet still allow free sliding of thesuture 26 therethrough so that it will not catch on the tendon 48 as thetines 16 and 18 are removed from the tunnel 50.

The invention has been described with reference to the preferredembodiments. Obviously, modifications and alterations will occur toothers upon reading and understanding the preceding detaileddescription. It is intended that the invention be construed as includingall such modifications and alterations insofar as they come within thescope of the appended claims or the equivalents thereof.

1. An instrument for implanting a graft into a bone hole, the instrumentcomprising: an elongated handle having a forked distal termination; thedistal termination comprising a first tine and a second tine defining aspace therebetween; a flexible member spanning the space between thefirst tine and the second tine whereby the graft can be received withinthe space against the flexible member and thereby manipulated into thebone hole.
 2. An instrument according to claim 1 wherein the first tinecomprises a open ended first notch at its distal end, the flexiblemember being received within the first notch.
 3. An instrument accordingto claim 2 wherein the flexible member having a first section betweenthe first tine and second tine, and a second section extending from thefirst notch proximally along the handle.
 4. An instrument according toclaim 3 wherein the second section is releasably attached to the handlewherein a user can release the flexible member from the handle to relaxtension in the flexible member.
 5. An instrument according to claim 2and further comprising the second tine comprising an open ended secondnotch, the flexible member being received in both the first notch andsecond notch and spanning the space therebetween.
 6. An instrumentaccording to claim 1 wherein at least one of the first tine and secondtine are flexible, the space between the first tine and second tinebeing adjustable by tension on the flexible member.
 7. An instrumentaccording to claim 2 wherein the handle is cannulated having alongitudinal cannulation opening to the space between the first tine andsecond tine.
 8. An instrument according to claim 7 and furthercomprising a guide wire passable through the cannulation and adapted tobe fixed into the bone hole whereby the instrument can be passed down tothe bone hole over the guide wire.
 9. An instrument according to claim 8wherein the first tine and second tine are curved about a centrallongitudinal axis of the instrument to accommodate to the bone hole. 10.An instrument according to claim 1 which is sterile and packaged in abacteria proof package. 11-17. (canceled)